Spectrum Laboratory Products, Inc. announced a voluntary recall of three lots of Epinephrine (L-Adrenaline) USP – a bulk active pharmaceutical ingredient – due to discoloration. The U.S. Food and Drug Administration published the recall notice Monday.
This product is used to manufacture or compound prescription products and Spectrum announced the recall following customer complaints, per the notice.
“Epinephrine is a critical medication used during life-threatening conditions which can affect any age and any person,” said a risk statement.
Conditions treated with epinephrine include: anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest.
“The use of a finished dose product manufactured or compounded with this recalled product could result in less-effective product, and incomplete treatment of life-threatening conditions including, low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack,” and death, the risk statement said.
However, Spectrum Laboratory Products, Inc. has not received any reports of adverse events related to the recall. Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles and enclosed in a vacuum sealed pouch. It was distributed directly from Spectrum facilities nationwide in the U.S. and to Canada.
“Spectrum Laboratory Products, Inc. is notifying its distributors and customers by certified mail, email and phone, and arranging for return of all recalled products,” said the notice. “Consumers, distributors, or retail pharmacies that have Epinephrine, USP catalog number EP130, which is being recalled, should stop use immediately and return to place of purchase.”
Consumers can contact Spectrum Laboratory Products, Inc. at 800-772-8786 or compliance@spectrumchemical.com Monday through Friday from 8 a.m.
to 5 p.m. PT. Consumers are advised to contact their physicians or healthcare providers if they experienced any problems that may be related to taking or using the product.
“Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax,” said the administration.
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